Invacare readies to submit final report to FDA
ELYRIA, Ohio – Invacare could be turning the corner on its “ongoing journey” to lift a consent decree with the Food and Drug Administration that has handicapped the company since late 2012.
An independent auditor on Feb. 9 issued its certification report for the third phase of the decree, indicating Invacare’s substantial compliance to the FDA’s quality system regulation or QSR, Matt Monaghan, chairman, president and CEO, announced during a Feb. 11 conference call to discuss fourth quarter and year-end financial results.
“While the third expert certification report is an important milestone, it is only one step forward in our ongoing journey toward an enhanced quality culture,” he said.
Invacare must now submit its own report to the FDA regarding its compliance status, as well as any observations to the auditor’s report. The FDA must accept both reports before the final phase of the consent decree, a re-inspection by the agency.
When asked when Invacare might submit its report, Monaghan said the company has been working on it all along, so it “shouldn’t be too long,” but wouldn’t elaborate.
“I wouldn’t want to surprise the FDA with what we submit,” he said. “There is a dialogue that goes along with that.”
While Invacare can’t predict when, or if, the FDA will accept the two reports, the agency has 30 days to re-inspect the company for compliance when, and if, it does, Monaghan said.
“Once they accept both of those, then the clock starts during which the FDA can begin its re-inspection,” he said. “Beyond that, though, there is no restraint on timing. You can’t predict how long the audit might take or whether the audit will be successful the first time through.”
In a nod to the fact that improvements to its quality system are continuous, Invacare has brought onboard John Watkins as its new senior vice president of quality assurance & regulatory affairs. Watkins’ experience includes leadership roles at Welch Allyn, Boston Scientific and Zimmer Biomet.
“John has an extensive career in medical device quality systems, and I am confident he will lead us forward as we continue to build an enterprise-wide quality culture,” Monaghan said.
Watkins replaces Doug Uelmen, who joined Invacare in 2011 and went on to lead the renovation of several key quality processes, and the expansion of quality and regulatory resources and expertise. He leaves the company in March.
Two previous reports have been submitted and accepted by the FDA. They cleared the way for the company to resume manufacturing and distributing parts, components, accessories and subassemblies; and design activities.
This third report was a longer time coming. Invacare announced in late 2013 that the auditor informed the company that it must make improvements in clearing a backlog in its updated complaint handling system before moving forward with the report.